NCT00923793

Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty

Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.

Detailed description

Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.

Conditions

• Skull Defects
• Cranioplasty

Interventions

Type	Name	Description
DEVICE	Titanium implant (CranioConstruct™)	One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered.
DEVICE	Hydroxylapatite (CustomBone)	Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.

Timeline

• Start date: 2009-06-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2009-06-18
• Last updated: 2015-05-21

Locations

1 site across 1 country: Germany